BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORAL RINSE (UNSPECIFIED VARIANT)

    MDR report key: 8148786 · Received December 10, 2018

    Report

    Report Number
    9615332-2018-00172
    Event Type
    Injury
    Date Received
    December 10, 2018
    Report Date
    November 11, 2018
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    9615332-2018-00172 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE ORAL RINSE (UNSPECIFIED VARIANT).

    Description of Event or Problem · 1

    I ENDED UP IN THE HOSPITAL WITH A SEVERE POTASSIUM DEFICIENCY [POTASSIUM DEFICIENCY]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF POTASSIUM DEFICIENCY IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL RINSE (UNSPECIFIED VARIANT)) MOUTH WASH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL RINSE (UNSPECIFIED VARIANT). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL RINSE (UNSPECIFIED VARIANT), THE PATIENT EXPERIENCED POTASSIUM DEFICIENCY (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT). BIOTENE ORAL RINSE (UNSPECIFIED VARIANT) WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE POTASSIUM DEFICIENCY WAS UNKNOWN. THE REPORTER CONSIDERED THE POTASSIUM DEFICIENCY TO BE RELATED TO BIOTENE ORAL RINSE (UNSPECIFIED VARIANT). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2018 VIA FACEBOOK. CONSUME POSTED THAT "I USED THIS FOR OVER 3 WEEKS WHEN MY MOUTH WAS SO DRY. IT WORKED TEMPORARILY, BUT I ENDED UP IN THE HOSPITAL WITH A SEVERE POTASSIUM DEFICIENCY. PLEASE EVERYONE TRY TO FIND THE CAUSE OF YOUR DRY MOUTH BEFORE MASKING IT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985600 BIOTENE ORAL RINSE (UNSPECIFIED VARIANT) ORAL RINSES LFD KIK CUSTOM PRODUCTS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O